5806
HIV Specimen Collection Guide
| Test Name | Monogram Test N* | LabCorp Test N* | Clinical Use | Viral Load Requirement | Specimen Volume |
|---|---|---|---|---|---|
| PhenoSense GT* | V7000 | 551690 | Determines viral phenotype and genotype resistance to antiretroviral drugs (NRTIs, NNRTI, and Pis). Viral replication capacity is also included. | ≥500 copies/mL | 3 mL plasma |
| HIV-1, Quantitative, RT-PCR, with Reflex to PhenoSense GT | Graphical: V1000G Nongraphical: V1000N | Graphical: 550510 Nongraphical: 550450 | Detect and quantitate HIV-1 in plasma with reflex to PhenoSense GT if viral load is ≥500 copies/mL. | N/A | 6 mL plasma |
| PhenoSense GT* Plus Integrase* | M7000 | 551920 | Determines viral phenotype and genotype resistance to antiviral drugs (NRTIs, NNRTI, Pis, and InIs). | ≥500 copies/mL | 5 mL plasma |
| HIV-1, Quantitative, RT-PCR, with Reflex to PhenoSense GT* Plus Integrase* | Graphical: V1000G Nongraphical: V1000N | Graphical: 550711 Nongraphical: 550625 | Detect and quantitate HIV-1 with reflex to PhenoSense GT Plus Integrase if viral load ≥500. | NA | 6 mL plasma |
| PhenoSense* | V3200 | 551800 | Determines viral phenotype resistance to antiretroviral drugs (NRTIs, NNRTI, and Pis). Viral replication capacity is also included. | ≥500 copies/mL | 3 mL plasma |
| HIV-1, Quantitative, RT-PCR, with Reflex to PhenoSense | Graphical: V1000G Nongraphical: V1000N | Graphical: 550520 Nongraphical: 550470 | Detect and quantitate HIV-1 in plasma with reflex to PhenoSense if viral load is ≥500 copies/mL. | N/A | 6 mL plasma |
| PhenoSense Integrase* | S3200 | 550230 | Determines viral phenotype resistance to integrase inhibitors. Viral replication capacity is also included. | ≥500 copies/mL | 3 mL plasma |
| PhenoSense Entry* | E2000 | 550240 | Determines viral phenotype resistance to enfuvirtide. | ≥1000 copies/mL | 3 mL plasma |
| GenoSure PRime** | P5000 | 551700 | Detect resistance in HIV-1 to antiretroviral drugs (NRTIs, NNRTI, Pis, and InIs) | ≥500 copies/mL | 5 mL plasma |
| HIV-1, Quantitative, RT-PCR, with Reflex to GenoSure PRime | Graphical: V1000G Nongraphical: V1000N | Graphical: 550630 Nongraphical: 550655 | Detect and quantitate HIV-1 in plasma with reflex to GenoSure PRime if viral load is ≥500 copies/mL. | N/A | 6 mL plasma |
| GenoSure® MG* | G5000 | 551697 | Detect resistance in HIV-1 to antiretroviral drugs (NRTIs, NNRTI, and Pis) | ≥500 copies/mL | 5 mL plasma |
| HIV-1, Quantitative, RT-PCR, with Reflex to GenoSure MG | Graphical: V1000G Nongraphical: V1000N | Graphical: 550422 Nongraphical: 550432 | Detect and quantitate HIV-1 in plasma with reflex to GenoSure MG if viral load is ≥500 copies/mL. | N/A | 6 mL plasma |
| GenoSure Archive® | R6000 | 551776 | Detect resistance of HIV-1 to protease, reverse transcriptase and integrase inhibitors in cell-associated viral DNA. | For patients with an undetectable viral load. | 4 mL whole blood |
| Trofile® DNA | E3600 | 829670 | Detect HIV-1 coreceptor tropism to determine eligibility for a CRS antagonist. | For patients with an undetectable viral load. | 4 mL whole blood |
| Trofile® | E3100 | 553100 | Detect HIV-1 coreceptor tropism to determine eligibility for a CRS antagonist. | ≥1000 copies/mL | 3 mL plasma |
| HIV-1, Quantitative, RT-PCR, with Reflex to Trofile® | Graphical: V1000G Nongraphical: V1000N | Graphical: 550390 Nongraphical: 550310 | Detect and quantitate HIV-1 in plasma with reflex to Trofile if viral load is ≥1000 copies/mL. | N/A | 6 mL plasma |
| Trofile® Select | E3000T | 553355 | Allows for the determination of HIV-1 coreceptor tropism status, by which the appropriate assay, Trofile® or Trofile® DNA, is selected through an initial prescreening viral assessment. The coreceptor tropism status may be used to determine eligibility for CRS antagonist therapy, such as maraviroc (Selzentry®). | N/A | 5 mL plasma and 4 mL whole blood |
| HIV-1, Quantitative, Real-Time PCR (Graphical or Nongraphical) | Graphical: V1000G Nongraphical: V1000N | Graphical: 550420 Nongraphical: 550430 | Quantitative measurement of HIV-1 RNA in plasma. | N/A | 3.5 mL plasma |
*Note: This procedure may not be successful when the HIV viral load is <500 copies/mL plasma. If there is insufficient virus to produce results, HIV-1 RNA quantitation will be performed to confirm viral load, and the procedure will be billed at the account’s prevailing fee.
Plasma Sample Collection and Preparation for Resistance assays and Trofile (excluding Trofile DNA)
- Collect whole blood by venipuncture.
For tests with sample volumes of 3.0 or 3.5 mLs plasma either:
- Two EDTA (lavender-top) tubes (preferred)
- OR Two 5.0 mL PPT (pearl-top) tubes
For tests with sample volumes of 5.0 or 6.0 mLs plasma either:
- Three EDTA or three 5.0 mL PPT tubes when ordering a viral load assay with reflex to a resistance assay. Note: PPT tubes are acceptable for collecting viral load and resistance testing, but samples for viral load assays cannot be frozen in a PPT tube; viral load assays must be transferred to a screw-cap tube.
Spin immediately at 1,000 to 1,200 g for 10 to 15 minutes at room temperature.
Don’t leave samples in centrifuge after spinning.
Prepare for freezing:
- For PPT samples, freeze directly in tube.
- Note: Specimens collected in a PPT tube for viral load assays MUST be transferred to a screw-cap tube prior to freezing.
- OR For EDTA samples, aliquot plasma and transfer to screw-cap tube.
Freeze immediately at -20°C. Sample should be frozen solid before shipping. Note: Do not place samples on dry ice until completely frozen.
Whole Blood Sample Preparation for Trofile® DNA and GenoSure Archive®
Draw 4 mL of whole blood into an EDTA (lavender-top) tube.
DO NOT CENTRIFUGE.
- Both plasma and whole blood samples must be collected and processed.
CHECKLIST FOR MORE SUCCESSFUL RESULTS
- Verify that your patient’s viral load is appropriate for the assay.
- When you draw blood, be sure there’s enough specimen in each tube.
- Process the sample according to the appropriate instructions.
- Do NOT leave samples in the centrifuge after spinning. (Note: Trofile DNA and GenoSure Archive specimens should NOT be centrifuged.)
- If frozen samples thaw, DO NOT refreeze.
TOP 3 REASONS TEST CANNOT BE PERFORMED:
- Low viral load.
- Unfrozen specimens or specimens exposed to repeated freeze-thaw cycles.
- Unlabeled specimens.